Self-cinching suture construct apparatus

ABSTRACT

A suture construct apparatus, including a self-cinching suture member having a first strand, a second strand, a sleeve defined on the second strand, and a self-cinching suture member fixed loop with a sheath positioned on the self-cinching suture member. The suture construct apparatus may further include an anchor disposed on the self-cinching suture member, a self-cinching suture member shuttling suture disposed on the self-cinching suture member fixed loop, and a sheath removably disposed around at least a portion of the self-cinching suture member. The first strand may pass through the sleeve and form a self-cinching suture member free end. The first strand may also be axially moveable through the sleeve.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 15/937,390 filed Mar. 27, 2018 entitled SELF-CINCHING SUTURECONSTRUCT APPARATUS which is a continuation of U.S. patent applicationSer. No. 15/783,498 filed Oct. 13, 2017 entitled SELF-CINCHING SUTURECONSTRUCT APPARATUS (now U.S. Pat. No. 9,924,939) which is acontinuation in part of U.S. patent application Ser. No. 15/643,173filed Jul. 6, 2017 entitled SUTURE BUTTON CONSTRUCT FOR SURGICALPROCEDURES, and is a non-provisional of U.S. Provisional PatentApplication No. 62/723,620 filed Aug. 28, 2018 entitled SELF-CINCHINGSUTURE CONSTRUCT APPARATUS, which are all hereby incorporated byreference in their entireties.

A portion of the disclosure of this patent document contains materialthat is subject to copyright protection. The copyright owner has noobjection to the reproduction of the patent document or the patentdisclosure, as it appears in the U.S. Patent and Trademark Office patentfile or records, but otherwise reserves all copyright rights whatsoever.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

REFERENCE TO SEQUENCE LISTING OR COMPUTER PROGRAM LISTING APPENDIX

Not Applicable

BACKGROUND OF THE INVENTION

The present invention relates generally to surgical devices and methodsand more particularly to suture devices and methods to secure damagedsoft tissue structure.

Various types of sutures, suture fixation devices, and associatedmethods are known in the art for securing a suture in a desired positionand/or at a desired tension during and after surgical procedures. Inmany surgical procedures, a transosseous hole is drilled through aportion of bone, forming a rigid tunnel for passing a surgicalinstrument or a suture. The drilled tunnel includes a proximal openingadjacent a tissue repair site where a procedure for the repair of tissueis generally performed, such as but not limited to a procedure to repaira meniscus root tear in a knee. The drilled tunnel generally alsoincludes a distal opening at a location remote from the repair site.

During surgical procedures, one or more sutures are attached to thetissue to be repaired. A free end of the suture is inserted through anopening of the drilled tunnel near the tissue and passed through thetunnel to a tunnel exit. The suture then exits the tunnel and istensioned to manipulate the damaged tissue into a desired anatomicalposition. The free end of the suture extending out of the tunnel exitmust be pulled tight to maintain tension on the tissue following theoperation. After tension is applied, the held in place using an anchoror suture button to maintain the desired tension.

Numerous types of sutures, suture buttons, and suture anchors are knownin the art for tying off sutures on the distal end of transosseoustunnels for maintaining tension. However, such conventional sutures,suture buttons, and suture anchors are often inadequate and may lead tounintentional release of the applied tension on the suture over time.This release of tension may cause the tissue to heal improperly, leadingto discomfort and pain at the joint and potentially requiring additionaloperations to reapply the necessary tension.

For example, with regard to conventional sutures, such devices formeniscus root repair and other operations on the knee have adisadvantage of requiring one or more knots on the outside of the drilltunnel opening to secure the soft tissue in place. The knots may rubagainst the soft tissue, causing discomfort or irritation. Likewise,knots positioned near the drill tunnel exit also cause discomfort andirritation.

Additionally, when the suture is pulled tight to reduce the soft tissueto its desired anatomical position, the suture has a tendency to allowthe button to move slightly away from the bone. The button may alsoinadvertently move away from the bone when a knot is tied in the sutureat the button site. Any gap between the button and the bone may resultin a loss of tension in the suture.

Further, knotted suture constructs for meniscus root repair may slip orloosen over time as knots work loose. Such loosening of knotted sutureconstructs may cause damage to the tissue, improper healing, and furtherinjury.

What is needed, then are improvements in suture construct devices andmethods for surgical procedures.

BRIEF SUMMARY

This Brief Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

One aspect of the disclosure is a suture construct apparatus, includinga self-cinching suture member having a first strand, a second strand, asleeve defined on the second strand, and a self-cinching suture memberfixed loop. The suture construct apparatus may further include a sheathremovably disposed around at least a portion of the self-cinching suturemember. The first strand may pass through the sleeve and form aself-cinching suture member free end. The first strand may be axiallymoveable through the sleeve.

Another aspect of the disclosure is a suture construct apparatus,including a self-cinching suture member including a first strand, asecond strand, a sleeve defined on the second strand and a self-cinchingsuture member fixed loop. The suture construct apparatus may furtherinclude a continuous loop device disposed on the first strand, acontinuous-loop shuttling suture disposed on the continuous loop, and aself-cinching suture member shuttling suture disposed on theself-cinching suture member fixed loop. The first strand may passthrough the sleeve and form a self-cinching suture member free end. Thefirst strand may be axially moveable through the sleeve.

A further aspect of the disclosure is a suture construct apparatus,including a self-cinching suture member including a first strand, asecond strand, a sleeve defined on the second strand and a self-cinchingsuture member fixed loop. The suture construct apparatus may furtherinclude an anchor disposed on the first strand of the of theself-cinching suture member. The first strand may pass through thesleeve and form a self-cinching suture member free end. The first strandmay be axially moveable through the sleeve.

Numerous other objects, advantages, and features of the presentdisclosure will be readily apparent to those of skill in the art upon areview of the following drawings and description of a preferredembodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of an embodiment of a portion ofknee including a meniscal root tissue injury.

FIG. 2 is a perspective view of an embodiment of a self-cinching sutureconstruct apparatus in accordance with the present disclosure.

FIG. 3 is a perspective view of an embodiment of a self-cinching sutureconstruct apparatus having a sheath.

FIGS. 4A-4I are sectional views of various embodiments of aself-cinching suture construct apparatus having a sheath and variousanchors.

FIGS. 5A-5I illustrates an exemplary method of using a self-cinchingsuture construct apparatus having a sheath.

FIG. 6A is a side view of an embodiment of a self-cinching sutureinstallation apparatus having a sheath disposed in a cartridge.

FIG. 6B is a side view of an embodiment of a cartridge housing aself-cinching suture.

FIG. 7 is a side view of a self-cinching suture installation apparatuswhere a suture is disposed around a cartridge.

FIGS. 8A-8F illustrate an exemplary method of deploying a self-cinchingsuture construct apparatus using a self-cinching suture installationapparatus.

FIGS. 9A-9C illustrate an exemplary method of securing a self-cinchingsuture construct apparatus on a suture button.

FIG. 10 is a perspective view of an embodiment of a self-cinching sutureconstruct apparatus implementing two shuttling sutures.

FIG. 11A-11E illustrate an exemplary method of using a self-cinchingsuture construct apparatus implementing two shuttling sutures.

FIG. 12 is a perspective view of an exemplary interface between damagedtissue and the implementing a self-cinching suture construct apparatus.

FIG. 13A is a perspective view of an exemplary embodiment of an anchordisposed on a self-cinching suture device.

FIGS. 13B-13D are perspective views of an exemplary soft anchor used tosecure damaged tissue.

FIGS. 14A-14L are perspective views of an exemplary disk anchor used tosecure damaged tissue.

FIGS. 15A-15D are perspective views of various embodiments of anchorsused to secure damaged tissue.

FIGS. 16A and 16B are perspective views of various embodiments ofself-cinching sleeves.

FIGS. 17A and 17B are perspective views of an exemplary embodiment of ananchor securing damaged tissue and reducing the damaged tissue to ananatomical position.

FIGS. 18A and 18B are perspective views of an embodiment of aself-cinching suture construct apparatus having a sheath.

FIGS. 19A and 19B are perspective views of an embodiment of aself-cinching suture construct apparatus having various embodiments ofanchors.

DETAILED DESCRIPTION

While the making and using of various embodiments of the presentinvention are discussed in detail below, it should be appreciated thatthe present invention provides many applicable inventive concepts thatare embodied in a wide variety of specific contexts. The specificembodiments discussed herein are merely illustrative of specific ways tomake and use the invention and do not delimit the scope of theinvention. Those of ordinary skill in the art will recognize numerousequivalents to the specific apparatus and methods described herein. Suchequivalents are considered to be within the scope of this invention andare covered by the claims.

In the drawings, not all reference numbers are included in each drawing,for the sake of clarity. In addition, positional terms such as “upper,”“lower,” “side,” “top,” “bottom,” etc. refer to the apparatus when inthe orientation shown in the drawing. A person of skill in the art willrecognize that the apparatus can assume different orientations when inuse.

The present disclosure provides a self-cinching suture construct for usein surgical procedures, including but not limited to operations on theknee. As shown in FIG. 1, an embodiment of a knee 110 showing the upperend of a tibia 112 including a medial meniscus 116 and a lateralmeniscus 118. The medial meniscus 116 includes a posterior root 128 andan anterior root 130. The lateral meniscus 118 includes a posterior root124 and an anterior root 126. Each root is attached to the tibia atlocal tissue attachment sites along the tibial plateau 114. Varioustypes of injuries may lead to one or more root tears or injuries in thelateral or medial meniscus. An example of a root tear 132 on the lateralposterior root 124 is shown in FIG. 1.

Although various figures refer to an exemplary lateral posterior roottear injury, the devices and methods of the present disclosure areapplicable to many different types of injuries, including but notlimited to tears and injuries in the anterior lateral meniscus andposterior lateral meniscus as well as the anterior medial meniscus andposterior medial meniscus. The examples demonstrating application to alateral posterior meniscus root tear are offered only as a non-limitingexample. Likewise, one skilled in the art will recognize otherimplementations of the devices and methods disclosed herein for use inother surgical procedures beyond those relating to the meniscus.

The present disclosure generally provides a self-cinching, knotlesssuture construct device for repairing a meniscus root tear in a knee. Asshown in FIG. 2, an embodiment of a suture construct device 10 isillustrated. The suture material may include any suitable suturematerial known in the art. The device 10 includes a meniscal end and abutton end. The meniscal end is generally secured to the damagedmeniscus and is operable to reduce the damaged meniscus to theappropriate anatomical position to allow healing and prevent furtherdamage. The button end is generally securable to a suture button. Whenthe device 10 is secured to the meniscus at the meniscal end and thesuture button at the button end, the device 10 may be positioned througha transosseous tunnel 138 in a patient's bone during a meniscal roottear repair procedure, for example.

The device 10 may generally include a continuous loop 22 and aself-cinching suture member 32. The device may likewise implement ananchor 21 in place of the continuous loop 20, and the anchor may includea variety of embodiments, which will be discussed in further detaillater in this description. The self-cinching suture member 32, orknotless repair suture 32, may generally include a self-cinching sutureleading end 34 positioned on a forward end toward the continuous loop22.

Referring further to FIG. 2, a self-cinching suture sleeve 40 isdisposed on the self-cinching suture member 32. In some embodiments,self-cinching suture member 32 is constructed of a suture materialhaving an annular cross-sectional profile, forming an elongated tube.Such suture material may include braided or non-braided suture material.In some embodiments, self-cinching suture sleeve 40 is defined withinthe interior hollow body of the suture material.

For example, a self-cinching suture member free end 36 may be passedthrough a self-cinching suture sleeve segment 40 of the self-cinchingsuture member body, as shown in FIG. 2. The segment of the suture bodysurrounding the passed-through portion forms a self-cinching suturesleeve 40 around the suture strand of the self-cinching suture memberfree end 36.

Thus, a portion of the suture strand between the self-cinching suturemember free end 36 and the self-cinching suture leading end 34 may slidethrough the self-cinching suture sleeve 40. As tension is applied to thesuture member, the self-cinching suture sleeve 40 may tighten around thesuture strand passing through self-cinching suture sleeve 40, therebysecuring or locking the suture strand in place relative to theself-cinching suture sleeve 40. The self-cinching suture sleeve 40provides a clamping effect against the strand of suture material passingthrough the self-cinching suture sleeve 40. The clamping effect preventsthe strand from inadvertently loosening during use. More specifically,during use, when the self-cinching suture member 32 is pulled tight, theself-cinching suture sleeve 40 restricts axial translation of theself-cinching suture member free end 36. As such, the suture member maybe referred to as a “self-cinching” or “knotless” suture construct.

Referring further to FIG. 2, another feature of the self-cinching suturemember 32 includes a retaining structure such as a self-cinching suturefixed loop 42 formed at the self-cinching suture trailing end 44. Duringa surgical procedure, a suture button 270 or suture anchor may besecured to the device 10 at the self-cinching suture fixed loop 42. Theapplication of tension to self-cinching suture member free end 36 causesthe self-cinching suture member 32 to be generally drawn back toward thecontinuous loop 20. This motion effectively forms an adjustable loop 38which closes as tension is applied.

As various embodiments of the device will be discussed herein, thediscussion will be divided into separate sections disclosing generalembodiments. Each general embodiment includes various other embodimentsand features that will be discussed in each respective section. Some ofthese general embodiments include a sheathed device 210 and doubleshuttling suture device 310. Further, each embodiment of the device 10may implement various embodiments of an anchor 21 in place of thecontinuous loop 20.

One embodiment of the suture construct device 10 includes a sheatheddevice 210. FIGS. 3 and 4 demonstrate an exemplary embodiment of asheathed device 210. As seen in FIG. 3, the sheathed device maygenerally include a continuous loop 220, a self-cinching suture member232, and a sheath 250. The continuous loop 220 may also be substitutedwith a variety of anchors 221, which will be discussed in furtherdetail, but is generally coupled to the self-cinching suture member 232.For example, FIGS. 4B-4I demonstrate a self-cinching suture member 232implementing various embodiments of anchors 221. As seen in FIG. 3, thesheath 250 may cover at least a portion of the self-cinching suturemember 232.

Referring now to FIG. 4A, in some embodiments, the self-cinching suturemember 232 includes a self-cinching suture leading end 234 positioned ona forward end toward the continuous loop 220, a self-cinching suturesleeve 240 is disposed on the self-cinching suture member 232, and aself-cinching suture member free end 236. The self-cinching suturemember free end 236 may be passed through the self-cinching suturesleeve 240. Thus, a portion of the suture strand between theself-cinching suture member free end 236 and the self-cinching sutureleading end 234 may slide through the self-cinching suture sleeve 240and the portion forming an adjustable loop 238.

The self-cinching suture member 232 may also include a self-cinchingsuture fixed loop 242 formed at the self-cinching suture trailing end244, the fixed loop 242 operable to retain a suture button 270 or sutureanchor. The fixed loop 242 may also be coupled to a sacrificial suture260. The sacrificial suture 260 may include a coupling portion 262 forcoupling to the fixed loop 242 of the self-cinching suture member 232and a sacrificial suture strand 264. The sacrificial suture strand 264may be operable to allow a user to grasp and manipulate the device 10for ease of use. The sacrificial suture 260 may also include a retainingportion 266. The retaining portion 266 may be operable to retain aportion of the self-cinching suture member free end 236. The retainingportion 266 allows for the device 10 to have the profile of onecontinuous strand, minimizing the loose ends to the two loose ends ofthe strand. Having only two loose ends may be beneficial specifically inapplication in which the device is to be inserted or threaded intoanother device or space, such as damaged tissue of a patient.

With further reference to FIG. 4, the sheath 250 may be installed on theself-cinching suture member 232. The sheath 250 may comprise a structureformed of a variety of materials, including similar suture materials asused in the various other portions of the suture construct device 10.The sheath 250 may form a hollow interior 252 with an opening 254 formedat a proximate end 256 of the sheath 250. In some embodiments, thesheath may have a second opening at a distal end 258 of the sheath 250.The hollow interior 252 and the open end 254 are shaped to receive andretain at least a portion of the self-cinching suture member 232. Insome embodiments, the sheath 250 may retain the self-cinching sutureleading end 234, the self-cinching suture sleeve 240, the self-cinchingsuture member free end 236, the self-cinching suture fixed loop 242, andthe sacrificial suture 260. A portion of the self-cinching suture member232 may be exposed because the sheath 250 may not retain the entireself-cinching suture member 232. For example, the adjustable loop 238 ofthe self-cinching suture member 232 and the continuous loop 220 are notretained in the sheath 250. In some embodiments, the sheath 250 istapered.

FIGS. 5A-5I demonstrate an exemplary embodiment of the sheathed device210 being installed onto a meniscal root 124. The distal end 258 of thesheath 250 is inserted through the meniscal root 124 either through apre-formed hole or is inserted via a secondary device such as a needleor any other device as known by one of skill in the art. When the distalend 258 of the sheath has been inserted through the meniscal root 124,the sheathed device 210 may be advanced through the meniscal root 124.In those embodiments in which the sheath 250 is tapered, the hole in themeniscal root 124 may be dilated via the sheath 250 to the appropriatesize to accommodate the sheathed device 210 and prevent tear out. Thesheath 250 may also be operable to provide a smooth surface for passingthe sheathed device 210 through the meniscal root 124 without variouscomponents of the self-cinching suture member 232 catching in themeniscal root 124. As such, the exterior surface of the sheath 250 maycomprise a smooth surface operable to provide minimal friction betweenthe sheath 250 and the meniscal root 124.

As seen in FIG. 5C, the distal end 258 of the sheath 250 may be insertedthrough the continuous loop 220. In this embodiment, a continuous loop220 is implemented for securing sheathed device 210 to the damagedtissue. Inserting the distal end 258 of the sheath 250 through thecontinuous loop 220 allows the sheathed device 210 to form a girth hitcharound the meniscal root 124 to secure the sheathed device 210 to themeniscal root 124. In those embodiments in which an anchor 221 isimplemented, the step of passing the distal end 258 of the sheath 250through the continuous loop 220 is not necessary. In those embodimentsin which the anchor 221 is implemented, the sheath 250 may be advancedthrough the meniscal root 124 until the anchor 221 engages the meniscalroot 124, thus providing simple installation of the sheathed device 210.

Referring now to FIG. 5D, when the distal end 258 of the sheath 250 ispassed through the continuous loop 220, the distal end 258 may betensioned such that the sheath 250 and the sheathed device 210 generallyadvance through the meniscal root 124 until a girth hitch is formed onthe meniscal root 124, as seen in FIG. 5E. Generally, by inserting thedistal end 258 of the sheath 250 and advancing the sheathed device 210through the damaged tissue, the sheathed device 210 is only passingthrough the damaged tissue in one direction (one-step passage) andminimizes the contact between the sheathed device 210 and the damagedtissues.

Once the sheathed device 210 is secured to the damaged tissue, agrabbing device 290 may be passed through a transosseous tunnel 138bored through the patient's tibia in order to secure the sheathed device210. In some embodiments, the grabbing device 290 may include a loopednitinol wire or a hook. The grabbing device 290 may retain a portion ofthe sheathed device 210 such that when the grabbing device 290 isretracted from the transosseous tunnel, the sheathed device 210 isshuttled through the transosseous tunnel, as seen in FIGS. 5F and 5G.

Now referring to FIG. 5H, once the sheathed device 210 is secured to thedamaged tissue and shuttled through the transosseous tunnel, the sheath250 may be removed from the self-cinching suture member 232. After theself-cinching suture member 232 has been exposed, the self-cinchingsuture member 232 may be secured to a suture button 270 or suture anchorsuch that the damaged tissue (meniscal root 124 as shown in FIG. 5) isreduced to an anatomical position to promote healing and repair and toprevent further injury to the tissue. The securing of the self-cinchingsuture member 232 will be described in greater detail later in thisdescription.

Now referring to FIGS. 6 and 7, a self-cinching suture installationapparatus 286 is provided. The self-cinching suture installationapparatus 280 may include readily available components such as aCeterix® Novostitch® device. The self-cinching suture installationapparatus 280 may include a neck 282 and an insertion portion 284. Asdemonstrated in FIGS. 6A and 6B, one embodiment may include a cartridge286 for retaining the sheathed device 210. The cartridge may be formedto include a hollow chamber operable to house at least a portion of thesheathed device 210 and permit the sheathed device 210 to be deployed aswill be described hereafter. The cartridge 286 may retain the sheatheddevice 210 and may be loaded onto a self-cinching suture installationapparatus 280. FIG. 7 provides an alternative embodiment in which thecartridge 286 retains the sheathed device 210 on exterior portions ofthe cartridge 286. Other embodiments may be implemented as known tothose of skill in the art.

Referring to FIGS. 8A-8F, an exemplary deployment of a sheathed device210 by a self-cinching suture installation apparatus 280 is provided.The sheathed device 210 may be installed in or on a cartridge 286 suchthat a portion of the sheathed device 210 is retained by the cartridge286 and the continuous loop 220 is retained around the neck 282 of theself-cinching suture installation apparatus 280. In those embodiments inwhich the sheathed device implements an anchor 221, the anchor 221 maybe contained in or on the cartridge 286. The distal end 258 of thesheath 250 may be retained by the insertion portion 284 of theself-cinching suture installation apparatus 280. When the self-cinchingsuture installation apparatus 280 is moved proximate the damaged tissuesuch as the meniscal root 124, the self-cinching suture installationapparatus 280 may be activated. The insertion portion 284 will eithercreate a passage through the damaged tissue or it will pass through anexisting passage formed through the damaged tissue. A retaining tip 288of the self-cinching suture installation apparatus 280 will then retainthe distal end 258 of the sheath 250 as the insertion portion retractsand releases the distal end 258, as seen in FIG. 8B.

FIG. 8C depicts the self-cinching suture installation apparatus 280being translated away from the damaged tissue. During this movement, thedistal end 258 continues to be retained by the retaining tip 288 suchthat the sheathed device 210 advances through the passage in the damagedtissue. Likewise, as the self-cinching suture installation apparatus 280is translated away from the damaged tissue, the continuous loop 220translated axially down the neck 282 of the self-cinching sutureinstallation apparatus 280 towards the retaining tip 288.

FIG. 8D demonstrates the continuous loop 220 axially sliding off theneck 282 and over the retaining tip 288 such that the distal end 258 ofthe sheath 250 and portions of the sheathed device 210 pass through thecontinuous loop 220. As the distal end 258 is retracted away from thedamaged tissue, a girth hitch is formed on the damaged tissue as seen inFIG. 8E. In those embodiments where a continuous loop 220 is notimplemented to secure the sheathed device 210 to the damaged tissue, ananchor 221 may be implemented. The anchor 221 may engage the damagedtissue as the sheathed device 210 is pulled through the damaged tissueand the anchor 221 contacts the damaged tissue. Various embodiments ofthe anchor 221 will be shown and discussed hereafter.

Referring to FIG. 8F, once the continuous loop 220 is securely fastenedto the damaged tissue, the self-cinching suture installation apparatus280 may be further translated away from the damaged tissue. As thetension increases along the sheathed device 210 a user may disengage theself-cinching suture installation apparatus 280 and release the distalend 258 of the sheath 250. A user may implement this method directlythrough a transosseous tunnel such that the sheathed device 210 ispulled by the self-cinching suture installation apparatus 280 directlythrough the transosseous tunnel. In some embodiments, as shown in FIG.8F, as the tension increases, the distal end 258 of the sheath 250 maybe retained by the self-cinching suture installation apparatus 280 andthe sheath 250 may begin to slide off from the self-cinching suturemember 232 and the remaining components of the sheathed device 210 suchas the sacrificial suture 260. A user may implement this method when theneck 282 of the self-cinching suture installation apparatus 280 wasinserted through the transosseous tunnel. Thus, as the self-cinchingsuture installation apparatus 280 is translated away from the damagedtissue, the sheathed device 210 is shuttled simultaneously through thetransosseous tunnel.

Now referring to FIGS. 9A-9C, a suture button 270 or suture anchor maybe provided in combination with the sheathed device 210. After thesheathed device 210 has been installed on the damaged tissue and thesheath 250 has been removed from the self-cinching suture member 232 andthe remaining components of the sheathed device 210 such as thesacrificial suture 260, the suture button 270 may be coupled to theself-cinching suture member 232. In some embodiments, the sacrificialsuture strand 264 may be passed through a center passage 272 of thesuture button 270. In those embodiments in which the self-cinchingsuture member free end 236 is retained by the sacrificial suture 260, asthe suture button 270 is axially advanced along the sacrificial suture260, the self-cinching suture member free end 236 also passes throughthe center passage 272. In some embodiments the self-cinching suturemember free end 236 is retained by the sacrificial suture 260 in asacrificial suture sleeve 268 formed on the sacrificial suture strand264. In other embodiments, the self-cinching suture member free end 236may be coupled to the sacrificial suture 260 by an adhesive or be woveninto the sacrificial suture strand 264.

FIG. 9B demonstrates an exemplary embodiment in which the suture button270 and the center passage 272 are advanced along the self-cinchingsuture member 232. Once the suture button 270 has advance passed theself-cinching suture fixed loop 242, a user may use the self-cinchingsuture fixed loop 242 to secure the suture button 270 to theself-cinching suture member 232. As shown in FIG. 9C, the self-cinchingsuture fixed loop 242 may be passed back over a longitudinal end of thesuture button 270 such that the self-cinching suture fixed loop 242forms a girth hitch over the suture button 270. A user may use thesacrificial suture 260 in order to better maneuver the self-cinchingsuture fixed loop 242 over the longitudinal end of the suture button272. After the self-cinching suture fixed loop 242 is installed on thesuture button 272, the sacrificial suture 260 may be cut from theself-cinching suture fixed loop 242. As the sacrificial suture 260 isremoved from the sheathed device 210, the self-cinching suture memberfree end 236 may be removed or come loose from the sacrificial suture260.

Once the suture button 270 is secured to the self-cinching suture fixedloop 242, a user may then tension the self-cinching suture member 232 bypulling the self-cinching suture member free end 236 and advancing theself-cinching suture member free end 236 through the self-cinchingsuture sleeve 240. As the self-cinching suture member free end 236 isadvanced through the self-cinching suture sleeve 240, the suture button270 is pulled towards the transosseous tunnel 138 until the suturebutton is reduced on the surface of the bone, firmly rests on the bone,and is substantially flush with the bone. A user may apply tension tothe self-cinching suture free end 236 until the appropriate tension isapplied across the self-cinching suture member 232 and the damagedtissue is reduced to the correct anatomical position. The excessself-cinching suture member free end 236 may be cut at or near thecenter passage 272.

Thus, a user may engage and retain portions of tissue in a desiredposition using the sheathed device 210. As the sheathed device 210 isoperable to be installed through the damaged tissue such that the anchor221 (in those embodiments implementing an anchor 221) is the lastcomponent to pass towards the damaged tissue, many various embodimentsof the anchor 221 may be implemented to improve surgical outcomes andhealing by preventing tear through or failure of the sheathed device 210after installation.

Another embodiment of the device 10 includes the double shuttling suturedevice 310. Referring to FIG. 10, the double shuttling suture device 310includes a continuous-loop shuttling suture 312 forming a leadingcontinuous-loop shuttling suture free end 314. Continuous-loop shuttlingsuture 312 includes a continuous-loop shuttling suture fixed loop 316 atits trailing end opposite the leading continuous-loop shuttling suturefree end 314. Leading continuous-loop shuttling suture free end 314 onshuttling suture 312 is positioned for initial insertion into theinjured tissue for beginning a suture attachment procedure.

The embodiment of a double shuttling suture device 310 shown in FIG. 10is not drawn to scale, and the relative lengths, shapes and diameters ofthe various suture construct features may vary considerable based on thedesired application. This is likewise applicable to many of the FIGS ofthe application in order to demonstrate many of the features of thedevices.

Next to the continuous-loop shuttling suture 312, a ring-shapedcontinuous loop 322 is attached to the continuous-loop shuttling suturefixed loop 316. Continuous loop 322 forms a continuous ring passingthrough the opening formed by the shuttling suture fixed loop 316.Continuous loop 322 includes a continuous loop leading edge 324 and acontinuous loop trailing edge 326. Continuous loop leading edge 324provides the engagement location between continuous loop 322 andshuttling suture fixed loop 316. Continuous loop 322 includes anysuitable suture material known in the art. Continuous loop 322 may beformed by splicing or connecting tag ends of a strand of suture materialtogether. Similarly, continuous-loop shuttling suture fixed loop 316 maybe formed by splicing or connecting a tag end of continuous-loopshuttling suture 312 back onto itself to form a fixed loop.Alternatively, continuous loop 322 or continuous-loop shuttling suturefixed loop 316 may be integrally formed on each respective suture memberin a molding process.

A third, self-cinching suture member 332 is disposed on the doubleshuttling suture device joining continuous loop 322. The self-cinchingsuture member 332, or knotless repair suture 332, includes aself-cinching suture leading end 34 positioned on the forward end towardthe continuous loop 322. The self-cinching suture leading end 334 passesthrough the ring-shaped opening formed by continuous loop 322.Self-cinching suture member 332 is configured to pass through atransosseous tunnel 138 in a patient's bone during a meniscal root tearrepair procedure in some embodiments.

Referring further to FIG. 10, a self-cinching suture sleeve 340 isdisposed on the self-cinching suture member 332. In some embodiments,self-cinching suture member 332 is constructed of a suture materialhaving an annular cross-sectional profile, forming an elongated tube.Such suture material may include braided or non-braided suture material.In some embodiments, self-cinching suture sleeve 340 is defined withinthe interior hollow body of the suture material.

For example, a self-cinching suture member free end 36 may be passedthrough a self-cinching suture sleeve segment 340 of the self-cinchingsuture member body, as shown in FIG. 10. The segment of the suture bodysurrounding the passed-through portion forms a self-cinching suturesleeve 340 around the suture strand of the self-cinching suture memberfree end 336.

Thus, a portion of the suture strand between self-cinching suture memberfree end 336 and the self-cinching suture leading end 334 may slidethrough self-cinching suture sleeve 340. As tension is applied to thesuture member, the self-cinching suture sleeve 340 may tighten aroundthe suture strand passing through self-cinching suture sleeve 340,thereby securing or locking the suture strand in place relative to theself-cinching suture sleeve. Self-cinching suture sleeve 340 provides aclamping effect against the strand of suture material passing throughthe self-cinching suture sleeve. The clamping effect prevents the strandfrom inadvertently loosening during use. More specifically, during use,when self-cinching suture member 332 is pulled tight, self-cinchingsuture sleeve 340 restricts axial translation of self-cinching suturemember free end 336. As such, the suture member may be referred to as a“self-cinching” or “knotless” suture construct.

Referring further to FIG. 10, another feature of self-cinching suturemember 332 includes a retaining structure such as a self-cinching suturefixed loop 342 formed at the self-cinching suture trailing end 344.During a surgical procedure, a suture button 370 or suture anchor may besecured to double shuttling suture device 310 at the self-cinchingsuture fixed loop 342. The application of tension to self-cinchingsuture member free end 336 causes the self-cinching suture member 332 toslide through continuous loop 322 and to be generally drawn back towardthe continuous loop 322. This motion effectively forms an adjustableloop 338, which closes as tension is applied.

The double shuttling suture device 310 may further comprise aself-cinching member shuttling suture 360 forming a self-cinching membershuttling suture free end 364. Self-cinching member shuttling suture 360includes a shuttling suture fixed loop 362 at an end opposite theself-cinching member shuttling suture free end 364, the shuttling suturefixed loop 362 attached to the self-cinching suture fixed loop 342.Alternatively, self-cinching suture fixed loop 342 or shuttling suturefixed loop 362 may be integrally formed on each respective suture memberin a molding process. The self-cinching member shuttling suture free end364 on self-cinching member shuttling suture 360 may likewise bepositioned for initial insertion into the injured tissue for beginningthe suture attachment procedure.

An example of a double shuttling suture device 310 configured formeniscus root tear repair is shown in FIGS. 11A-11E. The doubleshuttling suture device 310 may include four main components: acontinuous-loop shuttling suture 312, a continuous loop 322, aself-cinching suture member 332, and a self-cinching member shuttlingsuture 360. Referring to FIG. 11A, the leading shuttling suture free end314 is inserted through the damaged tissue of a meniscus root 124. Theleading continuous-loop shuttling suture free end 314 may be inserted inthe torn meniscal root 124 using any suitable instrument for passing asuture through tissue. Likewise, the self-cinching member shuttlingsuture free end 364 may be inserted in the torn meniscal root 124 usingany suitable instrument for passing a suture through tissue. Thus, bothfree ends of the shuttling sutures are inserted in the torn meniscalroot 124. As the free ends 314, 364 are passed through the torn meniscalroot tissue, passage holes 134 a, 134 b are formed, creating openings inthe soft tissue of the injured tissue through which the suture materialof the shuttling suture 312 may slide.

Referring now to FIG. 11B, the free ends 314, 364 may be advancedthrough the damaged tissue. As the leading continuous-loop shuttlingsuture free end 314 is advanced through the tissue, the continuous loop322 may be positioned proximate and pulled through the damaged tissue,as demonstrated in FIG. 11C.

FIG. 11C further demonstrates that once the continuous-loop shuttlingsuture 312 has pulled the continuous loop 322 through the damagedtissue, the continuous-loop shuttling suture 312 may be removed. Theself-cinching member shuttling suture free end 364 may be inserted inand pulled through the continuous loop 322. When this occurs, theself-cinching member shuttling suture free end 364 is pulled andtensioned and a double hitch is formed on the tissue with two planes oftissue being captured, which provides additional fixation to the damagedtissue by the continuous loop 322, thus allowing for greater engagementwith the damaged tissue.

In alternative embodiments in which the user implements an anchor 321rather than the continuous loop 320, an alternative method of securementto the damaged tissue may be implemented, as one of skill in the artwould recognize.

Now referring to FIGS. 11D, 11E, and 12, the double shuttling suturedevice 310 may be secured to the damaged tissue. The remainder of themethod for reducing the damaged tissue to the correct anatomicalposition via a suture button 370 and a transosseous tunnel 138 issimilar to those previously described and disclosed in FIGS. 5 and 9.Thus, the double shuttling suture device 310 may be implemented inrepairing damaged tissue including meniscal root repairs. Furthermore,the various components as described in connection with the sheatheddevice 210 may likewise be implemented with the double shuttling suturedevice 310, including a sheath and a shuttling suture sleeve 268 as oneof skill in the art would recognize. In addition, the various componentsas discussed with regard to the double shuttling suture device 310 mayalso be used in connection with the sheathed device 210 as one of skillin the art would recognize.

As previously discussed, the various devices and embodiments mayimplement an anchor 21. Although this application discusses the use ofthe anchor 21 specifically with the meniscus, these same embodiments maybe implemented on a variety of tissues to provide securement of andinterface with tissues, both healthy and damaged, as would be recognizedby one of skill in the art.

Referring to FIG. 12, a user may secure a torn meniscal root 124 via adouble hitch, where the suture material and the double hitch passesthrough two planes of the meniscal root 124. For example, a continuousloop 20 may be implemented to form the double hitch. When a fixed loopis implemented, the fixed loop may include a double fixed loop or afixed loop having the adjoining component passing through the fixed loopmaterial. Alternatively, disk anchors may provide a surface that mayrest flush with the damaged tissue and prevent tear through of thefixation and the damaged tissue.

A variety of disk anchors may be implemented including a disk 412 with aloop 414 or multiple loops. For example, a loop 414 may pass through aportion of the disk 412 and form an anchor 21. The loop 414 may includea single loop, a double loop, or any other loop known to one of skill inthe art. Various embodiments using a disc are disclosed in FIGS.14A-14L. The disk may be implemented using a variety of materials,including soft rubber, HMWPE, synthetic material, and a collagenscaffold. In some embodiments, the anchor 21 may include a variety ofloops, some of which are disclosed in FIGS. 15A-15D.

In those embodiments in which the anchor 21 does not implement a fixedloop, the anchor 20 may include a soft anchor 410. The soft anchor 410may include a material that is transversely bunched when deployed. Forexample, with reference to FIGS. 13A-13C, a section of suture may passthrough the superior and inferior surfaces of the soft anchor 410. Thesoft anchor 410 may be operable to prevent rubbing and friction betweenthe damaged tissue and the suture material when the suture material isbeing pulled through and adjusted in the damaged tissue. FIG. 13Bdemonstrates an exemplary embodiment in which a soft anchor 410 isimplemented. The suture may pass through the soft anchor 410 such thatthe suture is woven into the soft anchor 410. When both ends of thesuture and passed through a single passage in a tissue, the soft anchor410 will contact the exterior surface of the tissue and will begin tobunch, thus creating a surface area that prevents the soft anchor 410and the portion of the suture in contact with the soft anchor 410 frompassing through the tissue, as seen in FIG. 13C.

In another embodiment, the soft anchor 410 may include a material thatis axially bunched when deployed. For example, the soft anchor 410 maycomprise a sleeve that surrounds a portion of the suture. Thus, as thesuture is pulled through the damaged tissue, the soft anchor 410 bunchesand prevents the soft anchor and the remaining suture material frompassing through the damaged tissue, thus anchoring the suture to thedamaged tissue.

FIGS. 14A-14L provide exemplary embodiments of various anchors 21. Theanchors 21 may comprise a disk or multiple disks. Further, the disk mayhave a securing portion coupled to or passing through the disk. In someembodiments, there may be multiple securing portions operable to receivea suture. The disk may provide a surface that receives a normal force ofthe tissue when a force is applied to the disk, such as occurs duringtensioning. The disk may prevent the anchor from passing through thetissue.

FIGS. 15A-15D provide various embodiments of anchors 21. Likewise, theembodiments shown in these figures may be implements to form girthhitches when used in a manner similar as described with regards to thecontinuous loop 20.

Now referring to FIGS. 17A and 17B, an anchor 21 may be implemented tosecure a meniscal root 124. The anchor 21 may have a portion passingthrough the meniscal root 124 such that the disk is positioned betweenthe meniscal root 124 and the tibia. The securing portion may extend upthrough the meniscal root and turn back down towards the tibia and thetransosseous tunnel. When tension is applied, the meniscal root 124 maybe positioned in the correct anatomical position and the securingportion of the anchor 21 may compress a portion of the meniscal root,such that the securing portion rests flush with the remainder of thesurface of the meniscus. Thus, the securing portion and the disk areaxially spaced from the opposing cartilage tissue of the femur and donot rub or wear the cartilage as the femur and tibia move relative toone another.

FIGS. 18A and 18B provide exemplary embodiments of a sheathed deviceusing a continuous loops 220 and an anchor 221. FIGS. 19A and 19B depictexemplary embodiments of a suture implementing various embodiments ofthe anchor 221. FIGS. 18A, 18B, 19A, and 19B could include any of thevarious disclosed embodiments of the anchor as disclosed herein. Furtherembodiments of anchors 221 implemented on suture constructs are providedin FIGS. 4C-4I.

In some embodiments the self-cinching suture sleeve 40 may use analternative structure to allow the self-cinching suture 32 to preventthe self-cinching suture free end 36 from sliding through theself-cinching suture sleeve 40. For example, the self-cinching suturesleeve 40 may include the suture free end 36 passing back throughportions of the self-cinching suture 32 in a cross through embodiment.Exemplary embodiments of each self-cinching suture sleeve 40 areprovided in FIGS. 16A and 16B.

Thus, although there have been described particular embodiments of thepresent invention of a new and useful SELF-CINCHING SUTURE CONSTRUCTAPPARATUS, it is not intended that such references be construed aslimitations upon the scope of this invention.

What is claimed is:
 1. A suture construct apparatus, comprising: aself-cinching suture member including a first strand, a second strand, asleeve defined on the second strand, and a self-cinching suture memberfixed loop; a sacrificial suture disposed on the self-cinching suturemember fixed loop; and a sheath removably disposed around at least aportion of the self-cinching suture member, the sheath covering thesleeve defined on the second strand, wherein the first strand passesthrough the sleeve and forms a self-cinching suture member free end, andwherein the first strand is axially moveable through the sleeve.
 2. Theapparatus of claim 1, wherein the suture member comprises braided suturematerial.
 3. The apparatus of claim 2, wherein the suture membercomprises a hollow core.
 4. The apparatus of claim 1, further comprisinga continuous loop forming an opening disposed on the self-cinchingsuture member.
 5. The apparatus of claim 4, wherein the self-cinchingsuture member passes through the opening formed by the continuous loop.6. The apparatus of claim 5, wherein the self-cinching suture memberforms an adjustable loop between the continuous loop and the sleeve. 7.The apparatus of claim 6, wherein the sheath is removable by sliding thesheath off the self-cinching suture member in a direction away from thecontinuous loop.
 8. The apparatus of claim 7, wherein the continuousloop is configured to form a girth hitch.
 9. The apparatus of claim 8,wherein the self-cinching suture member is slidable through thecontinuous loop.
 10. The apparatus of claim 1, further comprising thesacrificial suture including a coupling portion and a sacrificial suturestrand.
 11. The apparatus of claim 10, further comprising a retainingportion on the sacrificial suture forming an opening in the sacrificialsuture strand.
 12. The apparatus of claim 11, wherein the self-cinchingsuture member free end is received in the opening in the retainingportion of the sacrificial suture.
 13. The apparatus of claim 12,wherein the sheath covers the sleeve on the self-cinching suture member.14. The apparatus of claim 13, wherein the sheath comprises a taperedhollow core material.